We have written in previous issues about the good work Public Citizen does and how important what they do is for the American people. For more than 40 years, Public Citizen has led the fight against unfettered corporate power and for justice, fairness and a healthier, more equitable state of affairs in the U.S. The organization fights hard to protect consumers and preserve their rights. For example, Public Citizen has worked continuously to:
• Preserve access to the courts;
• Eliminate forced arbitration;
• Ensure safe products in workplaces;
• Protect the public interest before the U.S. Supreme Court; and
• Defend victims of corporate abuse and wrongdoing.
Public Citizen’s longstanding, fearless work on drug and medical device safety, pressing for the removal of unsafe drugs and devices from the market and pushing for improvements in U.S. Food and Drug Administration (FDA) operations, may have been its best work. The FDA has failed to carry out its responsibilities on numerous occasions. Each year more than 100,000 people die from adverse drug reactions and another 2 million people are seriously injured. Unfortunately, the FDA has approved some drugs and medical devices that never should have been put on the market.
For example, the FDA dropped the ball on regulating a large compounding pharmacy, allowing it to continue to manufacture fungus-contaminated steroid injections that so far have sickened at least 620 people in 19 states, resulting in 39 deaths. What is particularly tragic for those who have been sickened or killed by the tainted drug and for their loved ones is that this situation was completely avoidable. Dr. Sidney Wolf, the Medical Director at Public Citizen, warned readers about compounding pharmacies in Worst Pills, Best Pills News back in 2001. He even had subsequent articles on the subject in 2006 and 2007. Even earlier, Dr. Wolf tried to get the FDA to act, but the agency never did.
Another example involves the drug Rezulin, which was approved by the FDA and later had to be pulled from the market. By the time the FDA banned Rezulin, it had caused hundreds of cases of liver damage, including 63 reported deaths. Worst Pills, Best Pills News warned of the potential danger a year and half before the FDA finally took Rezulin off the market. Unfortunately, the FDA is not the gold standard agency it once was. For that reason, Public Citizen has had to step up its efforts to keep the public informed. The following are some things Public Citizen has done:
• Public Citizen closely monitored the FDA where the drug review process is heavily dependent on industry financing. In fiscal year 2011, total drug industry user fees to the FDA central drug office – where drugs are reviewed – were $619 million. This means that approximately 60 percent of the total budget for reviewing drugs came directly from “regulated” companies. Because of this unhealthy financial relationship, Public Citizen has had to further increase the speed and intensity of its challenges to the safety of many drugs by petitioning the FDA to ban or relabel them. This responds to the urgent need to supplement the inadequate FDA (and Congressional) oversight of the drug industry.
• Public Citizen has had medical experts testify regularly at FDA advisory committee meetings about the safety of drugs, trying to stop dangerous drugs from being approved or arguing for them to be banned.
• Public Citizen formally petitions the FDA to remove unsafe drugs from the market or issue black box warnings. For drugs approved between 1975 and 2000, partly because the FDA sped up the approval process to accommodate the demands of the drug industry, one in five new drugs has to be removed from the market or receive a black box warning after FDA approval.
I encourage all of our readers to consider membership in Public Citizen. You can get more information on this organization at citizen.org. By joining, you can stand with Public Citizen, an organization that has the capabilities, experience and determination to lead the fight for more democracy, transparency, accountability and justice.
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